MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC PLUS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	E200-33M
Medical Device Problem Codes	Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2023, a 33mm epic plus was selected for implantation.During the procedure, while suturing the device into place, it was noted that the stent post had a deformation.The device was removed from patient anatomy and replaced with another 33mm epic plus, which was successfully implanted.The patient was reported to be in stable condition.
Event or Problem Description
It was reported that on 07 february 2023, a 33mm epic plus was selected for implantation.During the procedure, while suturing the device into place, it was noted that the stent post had a deformation.The device was removed from patient anatomy and replaced with another 33mm epic plus, which was successfully implanted.The patient was reported to be in stable condition and discharged.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
An event of stent post being deformed was reported.The valve was returned to abbott and investigation found no anomalies with the stent post and the cusps.The sewing cuff had fabric protruding from the cuff.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: EPIC PLUS
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL LTDA. REG#3001883144; 1301rua profvieira demendonça; bairro engenho nogueira 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16474211
• Report Number: 2135147-2023-00973
• Device Sequence Number: 7578936
• Product Code: LWR
• UDI-Device Identifier: 05415067033109
• UDI-Public: 05415067033109
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2026
• Device Model Number: E200-33M
• Device Catalogue Number: E200-33M
• Device Lot Number: BR00034699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male